The Prevalence of Liver Steatosis, Steatohepatitis, Fibrosis, and Hemosiderosis in Overweight and Obese US Military Dependent Pediatric Patients Using MR Elastography and Quantitative MRI
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- LiverMultiScan (LMS)
研究概览
简要总结
The prevalence of liver steatosis, steatohepatitis, fibrosis, and hemosiderosis in overweight and obese US Military dependent pediatric patients using MR Elastography and Quantitative MRI
详细描述
The purpose of this prospective study is to determine the prevalence NAFLD and of factors that have been associated with the diagnosis of fatty liver disease in overweight and obese children and adolescents and to determine the effectiveness of an intervention. In order to do this, we will also compare laboratory values and the ability/feasibility of new magnetic resonance technologies to first detect fatty liver disease and then to detect a difference in liver health between pediatric patients with a normal BMI and those with a BMI ≥85%. This study will consist of two phases and a reproducibility arm involving 19 voluntary subjects from Phase 1 and the control group.
Phase I:
Aim 1: To determine the prevalence and relative risk of liver fibrosis, steatosis, steatohepatitis and hemosiderosis in overweight and obese US Military dependents between ages 10 and 17 compared with normal weight controls using specialized MRI (LMS).
Aim 2: To compare results between MRI-LMS and MRE and to determine feasibility of one versus the other technology.
Aim 3: To compare liver health of controls and overweight/obese subjects to determine if there is a difference between groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DEERS eligible patients from the San Antonio Military Medical Center Healthy Habits clinic and pediatric endocrine, pediatric gastroenterology, adolescent, and general pediatric clinics, as well as from Wilford Hall's pediatric clinic.
- •Overweight (BMI > 85% and < (Control group) Normal BMI for age and gender (BMI <85%) 95% for age and gender) or obese (BMI >/= 95% for age and gender)
- •10 - 17 years old
- •Cognitively able to understand and provide written informed assent
- •Written informed consent from parent or legal guardian
- •Exclusion criteria:
- •Current or prior history of liver disease (to include chronic hepatitis B or C, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, HIV, biliary atresia, or Caroli/choledochal disease), or other known liver disease.
- •Pregnancy (self-reported or through positive beta HCG test during study)
- •Current use of hepatotoxic medications associated with liver disease/failure (antifungals, methotrexate, valproic acid)
- •Carrying an implantable active medical device such as a pacemaker, vagal nerve stimulator, defibrillator, or non-MRI compatible cochlear implant.
- •Previous claustrophobia/anxiety with MRI scanner or developmental delays that may result in failed MRI scan (e.g.autism, anxiety disorder)
- •Any alcohol use
- •Predicted family PCS/loss of benefits in the next 9 months (Phase II only)
排除标准
- 未提供
结局指标
主要结局
LiverMultiScan (LMS)
时间窗: 2 years
LMS Imagery will be used to for observance of the prevalence of liver fibrosis, steatosis, steatohepatitis and hemosiderosis on LMS in overweight and obese US Military dependents between ages 10 and 17
MRE
时间窗: 24
MRE imagery will be used as a comparison to the LMS imagery to help determine Liver stiffness as measured by MRE overweight and obese US Military dependents between ages 10 and 17after a 9 month intervention
次要结局
未报告次要终点